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Surgical Drapes

by Allegiance Healthcare Coporation

510(k) K002419

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK002419 Date15 Aug 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0576-03 FDA Unclassified (pre-2012) initiated 22 Jan 2003 on shared 510(k) K002419

    The product labeled as sterile had not been through its sterilzation cycle.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical site.

This device is supplied by Allegiance Healthcare Corporation and has received FDA 510(k) clearance under K002419. It is classified as a surgical drape (product code KKX), Class II with special controls. The device is intended for use in surgical settings as a protective barrier.

Other devices from Allegiance Healthcare Coporation